Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT06573268
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Da-vinci sp Versus xi Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total operation time (minutes)', 'timeFrame': 'on the surgery day (1 day)', 'description': 'Time for spending total surgery'}], 'secondaryOutcomes': [{'measure': 'Hospital stay days after surgery', 'timeFrame': 'after the surgery day (up to 2 weeks)', 'description': 'Hospital admission days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid', 'robotic surgical procedures', 'minimally invasive surgical procedures'], 'conditions': ['Thyroid Cancer', 'Thyroid Nodule']}, 'referencesModule': {'references': [{'pmid': '37475141', 'type': 'RESULT', 'citation': 'Choi YS, Choi JH, Jeon MS, Yu MJ, Lee HM, Shin AY, Yi JW. First Experience of Single-Port Robotic Areolar Approach Thyroidectomy. Clin Exp Otorhinolaryngol. 2023 Aug;16(3):275-281. doi: 10.21053/ceo.2023.00682. Epub 2023 Jul 5.'}, {'pmid': '34575159', 'type': 'RESULT', 'citation': 'Choi YS, Shin WY, Yi JW. Single Surgeon Experience with 500 Cases of the Robotic Bilateral Axillary Breast Approach (BABA) for Thyroid Surgery Using the Da-Vinci Xi System. J Clin Med. 2021 Sep 7;10(18):4048. doi: 10.3390/jcm10184048.'}]}, 'descriptionModule': {'briefSummary': 'One year comparative analysis between SPRA\\* versus BABA\\*\\* thyroid surgery. \\* SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery\n\n\\*\\* BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery', 'detailedDescription': "Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received robot thyroid surgery in our institution during study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received robot thyroid surgery in our institution\n* Retrospective review\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06573268', 'briefTitle': 'Da-vinci sp Versus xi Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': 'One-year Clinical Experiences of Single-port and Multi-port Robotic Thyroid Surgery in Single Institution', 'orgStudyIdInfo': {'id': '2024-08-015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPRA', 'description': 'patients who received da-Vinci SP robot thyroid surgery by SPRA method (Single Port Robotic Areolar)', 'interventionNames': ['Device: robot surgery device']}, {'label': 'BABA', 'description': 'patients who received da-Vinci SP robot thyroid surgery by BABA method (Bilateral Axillary Breast Approach)', 'interventionNames': ['Device: robot surgery device']}], 'interventions': [{'name': 'robot surgery device', 'type': 'DEVICE', 'description': 'SPRA used da-Vinci SP system (SPRA) BABA used da-Vinci Xi system (BABA)', 'armGroupLabels': ['BABA', 'SPRA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jin Wook Yi', 'investigatorAffiliation': 'Inha University Hospital'}}}}